Pfizer's COVID-19 vaccine found to be 100% effective and safe in 12-15 year olds, says company
The Pfizer-BioNTech Covid vaccine is extremely effective in adolescents between 12 to 15 years old, perhaps even more than in adults, the companies reported on Wednesday.
According to The New York Times, no infections were found among children who received the vaccine in a recent clinical trial; they produced strong antibody responses and experienced no serious side effects.
The company said in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.
These are topline results from a pivotal Phase 3 trial in 2,260 adolescents. "We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer, as quoted by the statement.
"We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year," he added.
"Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones," said Ugur Sahin, CEO and Co-founder of BioNTech.
As per NYT, the researchers recorded 18 cases of coronavirus infection in the placebo group, and none among the children who received the vaccine. Still, the low number of infections makes it difficult to be too specific about the vaccine's efficacy in the population at large, said Angela Rasmussen, a virologist affiliated with Georgetown University.
It further reported that the adolescents who received the vaccine produced nearly twice the levels of antibodies on average, compared with participants 16 to 25 years of age in an earlier trial of adults. They experienced the same minor side effects as older participants, although the companies declined to be more specific.
Pfizer and BioNTech plan to request from the US Food and Drug Administration an amendment to the emergency use authorization for their vaccine, in hopes of beginning vaccinations of older children before the start of the next school year. (ANI)